SEDECAL SA recalled six units of its mobile X-ray system on June 10, 2025. The equipment is not water-resistant and requires strict cleaning protocols. Improper cleaning could have serious consequences for users.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail
The recalled models include SM-40HF-B-D-C and 40KW70CDEMO.005. These models were distributed in California, Illinois, and New Jersey.
The mobile X-ray system is not water-resistant. Users must adhere to the cleaning instructions in the manual to avoid potential equipment damage and safety hazards.
No specific incidents have been reported in connection with this recall. However, improper cleaning could pose serious risks.
Stop using the mobile X-ray system immediately. Follow the recall instructions provided by the manufacturer and contact SEDECAL SA or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0280-2026 or contact SEDECAL SA directly.
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